{
    "spl_product_data_elements": [
        "Mucinex Childrens Multi-Symptom Cold and Flu Acetaminophen, Dextromethorphan HBr D&C YELLOW NO. 10 GLYCERIN FD&C RED NO. 40 WATER SODIUM BENZOATE AMMONIUM GLYCYRRHIZATE PROPYLENE GLYCOL DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN XANTHAN GUM SUCRALOSE ACETAMINOPHEN ACETAMINOPHEN ANHYDROUS CITRIC ACID EDETATE DISODIUM SORBITOL"
    ],
    "spl_unclassified_section": [
        "Drug Facts"
    ],
    "active_ingredient": [
        "Active ingredients (in each 10 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Acetaminophen 325 mg - Pain reliever/fever reducer Dextromethorphan HBr 10 mg - Cough suppressant"
    ],
    "purpose": [
        "Acetaminophen 325 mg - Pain reliever/fever reducer Dextromethorphan HBr 10 mg - Cough suppressant"
    ],
    "indications_and_usage": [
        "Uses \u25a0 temporarily relieves: \u25a0 cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants \u25a0 the intensity of coughing \u25a0 the impulse to cough to help your child get to sleep \u25a0 minor aches and pains \u25a0 sore throat \u25a0 headache \u25a0 temporarily reduces fever"
    ],
    "warnings": [
        "Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: \u25a0 more than 5 doses (50 mL) in 24 hours, which is the maximum daily amount for this product \u25a0 with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: \u25a0 skin reddening \u25a0 blisters \u25a0 rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use \u25a0 with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. \u25a0 in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson\u2019s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child\u2019s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product."
    ],
    "ask_doctor_or_pharmacist": [
        "Ask a doctor before use if the child has \u25a0 liver disease \u25a0 chronic cough that lasts such as occurs with asthma \u25a0 cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin When using this product do not use more than directed (see Overdose warning) Stop use and ask a doctor if \u25a0 pain or cough gets worse or lasts more than 5 days \u25a0 fever gets worse or lasts more than 3 days \u25a0 redness or swelling is present \u25a0 new symptoms occur \u25a0 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms. Keep out of reach of children."
    ],
    "keep_out_of_reach_of_children": [
        "Keep out of reach of children."
    ],
    "dosage_and_administration": [
        "Directions \u25a0 this product does not contain directions or complete warnings for adult use \u25a0 do not give more than directed (see Overdose warning) \u25a0 measure only with dosing cup provided \u25a0 do not use dosing cup with other products \u25a0 dose as follows or as directed by a doctor \u25a0 children 6 to under 12 years of age: 10 mL in dosing cup provided every 4 hours while symptoms last; do not give more than 5 doses in any 24-hour period \u25a0 children under 6 years of age: do not use"
    ],
    "other_safety_information": [
        "\u25a0 each 10 mL contains: sodium 6 mg \u25a0 store at 20-25\u00baC (68-77\u00baF) \u25a0 do not refrigerate"
    ],
    "inactive_ingredient": [
        "Inactive ingredients ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40, FD&C yellow no. 10, flavors, glycerin (soy), propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum"
    ],
    "questions": [
        "1-866-MUCINEX (1-866-682-4639)"
    ],
    "package_label_principal_display_panel": [
        "full carton label back label"
    ],
    "set_id": "4a9464cf-0c77-23d0-e063-6394a90a62f1",
    "id": "52564d42-21c6-f7df-e063-6294a90a5eb2",
    "effective_time": "20260521",
    "version": "2",
    "openfda": {
        "application_number": [
            "M012"
        ],
        "brand_name": [
            "Mucinex Childrens Multi-Symptom Cold and Flu"
        ],
        "generic_name": [
            "ACETAMINOPHEN, DEXTROMETHORPHAN HBR"
        ],
        "manufacturer_name": [
            "Reckitt Benckiser LLC"
        ],
        "product_ndc": [
            "72854-070"
        ],
        "product_type": [
            "HUMAN OTC DRUG"
        ],
        "route": [
            "ORAL"
        ],
        "substance_name": [
            "ACETAMINOPHEN",
            "DEXTROMETHORPHAN HYDROBROMIDE"
        ],
        "spl_id": [
            "52564d42-21c6-f7df-e063-6294a90a5eb2"
        ],
        "spl_set_id": [
            "4a9464cf-0c77-23d0-e063-6394a90a62f1"
        ],
        "package_ndc": [
            "72854-070-04"
        ],
        "is_original_packager": [
            true
        ],
        "unii": [
            "362O9ITL9D",
            "9D2RTI9KYH"
        ]
    }
}